FDA Grants Priority Review for Oral Achondroplasia Treatment in Children

The FDA has granted Priority Review to BridgeBio Pharma's New Drug Application for oral infigratinib, a potential treatment for children with achondroplasia. This designation highlights the urgent need for an oral targeted therapy for this genetic condition, with a PDUFA target action date set for February 4, 2027, indicating a potential regulatory decision soon.